Randomized, Comparative Study of Standard Dose of Rabeprazole versus Omeprazole in Gerd/Heartburn Symptom Relief

Randomized, Comparative Study of Standard Dose of Rabeprazole versus Omeprazole in Gerd/Heartburn Symptom Relief

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Author(s)

Author(s): Solomon O. A, Ajayi A.O, Solomon O.O, Olotu O.S

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DOI: 10.18483/ijSci.934 316 845 49-58 Volume 5 - Feb 2016

Abstract

Aim and objective: Gastro-esophageal reflux disease (GERD) is becoming increasingly common in Africa and indeed in Nigeria. Data on the efficacy of proton pump inhibitors in patients with GERD are scanty. In this study, we compared symptom relief rate after first dose treatment with Rabeprazole i.e. 20 mg versus omeprazole 20 mg in GERD/Heart burn patients. Materials and Methods: A total of 66 consenting consecutive patients attending the General Out- Patient Department (GOPD) Clinic of the Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, Nigeria presenting with symptoms of GERD/ heartburn were enrolled for the study. At enrolment, severity of symptom was graded on a five-point scale from none (0), mild (1), moderate (2), severe (3) and very severe (4). After enrolment, the patients were blindly randomized into two groups of 33 each which received either 20mg of Rabeprazole (Barole) stat; Rab- group or 20mg of Omeprazole stat; Ome- group. Symptom status was recorded in Case Report Form (CRF) at enrolment and 1hr 30 min after the treatment with stat dose of the proton pump inhibitor. Efficacy of proton pump inhibitor in symptom relief for GERD/heartburn was assessed by observing the degree of symptom relief after 1hr 30 minutes in each of treatment groups. Approval for the study was obtained from the Ethical and Research Committee of EKSUTH. Informed consent was equally obtained from each of the participants. Data obtained were analyzed using scale of comparison. Results: The mean age of the population studied was aged 33.98 ± 9.43 years (age range 18-50 years). 19 (28.8%) were males while 47 (71.2%) were females (M: F of 1:2.5). 25.8% of participants had regurgitation as a symptom in addition to heartburn while 40.9% had other GI symptoms. The mean symptom severity score at baseline were 2.33, 0.36 and 0.52 for heartburn, regurgitation and other symptoms respectively. Two of the Rabeprazole group who had ‘Very severe’ heartburn was after 1hr 30mins downgraded to 1(50%) ‘Mild’ and 1 (50%) ‘Moderate’ while only 1 participant with ‘very severe’ heartburn was downgraded to ‘severe’ heartburn, 1hr 30mins after Omeprazole.Ten in the Rabeprazole group who presented with ‘severe’ heartburn were downgraded 4(40%) to ‘moderate’ and 6 (60%) ‘Mild’ heartburn compare with Omeprazole group where 10 of the participants who had ‘severe’ heartburn were downgraded to 6(60%) and 4(40%) with ‘moderate’ and ‘mild’ heartburn respectively. One of the participants in Rabeprazole group who had ‘Severe’ regurgitation was downgraded to ‘Nil’ regurgitation, while none of the participants in Omeprazole group had ‘severe’ regurgitation. Two of the participants in Rabeprazole group had other symptoms of ‘moderate’ severity that were downgraded to ‘No symptoms’ compared with 5 participants in Omeprazole group with other symptoms with ‘moderate severity’ out of which 3(60%) and 2(40%) were downgraded to ‘mild’ and ‘No symptoms respectively’. Conclusion: Symptomatic relief is one of the primary goals in the management GERD. In this study Rabeprazole (Barole®) is more effective in downgrading the heartburn and other symptoms in GERD within 90 minutes of treatment compared to treatment with Omeprazole.

Keywords

GERD, Heart burns, Rabeprazole, Omeprazole and Symptom relief

References

  1. Kennedy T, Jones R. The prevalence of gastro-oesophageal reflux symptoms in a UK population and the consultation behaviour of
  2. patients with these symptoms. Aliment Pharmacol Ther 2000; 14: 1589-1594.
  3. Van Pinxteren B, Numans ME, Bonis PA, Lau J. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease like symptoms and endoscopy negative reflux disease (Cochrane Review). Cochrane Database Syst Rev 2000, 2: CD002095.
  4. Isolauri J, Luostarinen M, Isolauri E, Reinikainen P, Viljakka M, Keyrilainen O. Natural course of gastroesophageal reflux disease: 17±22 year follow-up of 60 patients. Am J Gastroenterol 1997; 92: 37- 41
  5. Nwokediuko S. Gastroesophageal reflux disease: a population based study. Gastroenterol Res. 2009;2:152-156
  6. Robinson M, Fitzgerald S, Hegedus R, et al. Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis. Aliment Pharmacol Ther 2002; 16: 445-454.
  7. Pace F, Pallota S, Casalini S, et al. A review of rabeprazole in the treatment of acid related diseases. Therapeutics and Clinical Risk Management 2007:3(3) 363–379
  8. Farley A, Wruble LD, Humphries TJ. Rabeprazole versus ranitidine for the treatment of erosive gastroesophageal reflux disease: a double-blind, randomized clinical trial. Rabeprazole Study Group. Am J Gastroenterol 2000; 95: 1894-1899
  9. DeVault KR. Overview of medical therapy for Gastroesophageal reflux disease.
  10. Gastroenterol Clin NorthAm1999; 28: 831-845.
  11. DeVault KR, Castell DO. Updated guidelines for the diagnosis and treatment of gastroesophageal reflux disease. Am J Gastroenterol 1999; 94: 1434-1442
  12. Van Pinxteren B, Numans ME, Bonis PA, Lau J. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease like symptoms and endoscopy negative reflux disease (Cochrane Review). Cochrane Database Syst Rev 2000, 2: CD002095.
  13. Prakash A, Faulds D. Rabeprazole. Drugs 1998; 55: 261-7. Dekkers CP, Beker JA,
  14. Thjodleifsson B, Gabryelewicz A, Bell NE, Humphries TJ. Double-blind, placebo-controlled comparison of rabeprazole 20 mg vs. omeprazole 20 mg in the treatment of erosive or ulcerative gastro-oesophageal reflux disease. Aliment Pharmacol Ther 1999; 13: 49-57.
  15. Robinson MG, Maton PN, Rodriguez S, Greenwood B, Humphries TJ. Effects of oral rabeprazole on oesophageal and gastric pH in patients with gastro-oesophageal reflux disease. Aliment Pharmacol Ther 1997; 11: 973-980.
  16. Cloud ML, Enas N, Humphries TJ, Bassion S. Rabeprazole in treatment of acid peptic diseases: results of three placebo controlled dose-response clinical trials in duodenal ulcer, gastric ulcer, and gastroesophageal reflux disease (GERD). Dig Dis Sci 1998; 43: 993-1000.
  17. Matsuki N, Fujita T, Watanabe N, et al. Lifestyle factors associated with gastroesophageal reflux disease in the Japanese population. J Gastroenterol. 2013;48: 340–349.
  18. Ronkainen J, Aro P, Storskrubb T, et al. Gastro-oesophageal reflux symptoms and health-related quality of life in the adult general population—the Kalixanda study. Aliment Pharmacol Ther. 2006; 23: 1725–1733.
  19. Wahlqvist P, Reilly M, Barkun AN. Systematic review: the impact of gastro-oesophageal reflux disease on work productivity. Aliment Pharmacol Ther. 2006; 24:259–272.
  20. Wahlqvist P, Karlsson M, Johnson D, Carlsson J, Bolge S, Wallander MA. Relationship between symptoms of gastroesophageal reflux disease and costs: a database study in a US cohort. Value Health. 2007; 10:A149.
  21. Wiklund I, Carlsson J, Vakil N. Gastroesophageal reflux symptoms and well-being in a random sample of the general population of a Swedish community. Am J Gastroenterol. 2006; 101: 18–28.
  22. Spechler SJ. Epidemiology and natural history of gastroesophageal reflux disease. Digestion 1992; 51 Suppl 1: 24-29
  23. Orlando RC. The pathogenesis of gastroesophageal reflux disease: the relationship between epithelial defense, dysmotility, and acid exposure. Am J Gastroenterol 1997; 92: 3S-5S; discussion 5S-7S
  24. Johnston BT, Collins JS, McFarland RJ, Love AH. Are esophageal symptoms reflux-related? A study of different scoring systems in a cohort of patients with heartburn. Am J Gastroenterol 1994; 89: 497-502
  25. Winters C Jr, Spurling TJ, Chobanian SJ, Curtis DJ, Esposito RL, Hacker JF 3rd, Johnson DA, Cruess DF, Cotelingam JD, Gurney MS. Barrett's esophagus. A prevalent, occult complication of gastroesophageal reflux disease. Gastroenterology 1987; 92: 118-124
  26. Ronkainen J, Talley NJ, Storskrubb T, et al. Erosive esophagitis is a risk factor for Barrett’s esophagus: a community-based endoscopic follow-up study. Am J Gastroenterol. 2011; 106:1946–1952.
  27. van Pinxteren B, Numans ME, Bonis PA, Lau J. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease. Cochrane Database Syst Rev. 2004;4 :CD002095.
  28. Kulig M, Leodolter A, Vieth M, et al. Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease—an analysis based on the ProGERD initiative. Aliment Pharmacol Ther. 2003; 18:767–776.
  29. Pace F, Negrini C, Wiklund I, Rossi C, Savarino V. Quality of life in acute and maintenance treatment of non-erosive and mild erosive gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2005; 22:349–356.
  30. Adachi K, Hashimoto T, Hamamoto N, et al., “Symptom relief in patients with reflux esophagitis: comparative study of omeprazole, lansoprazole, and rabeprazole,” Journal of Gastroenterology and Hepatology, vol. 18, no. 12, pp. 1392–1398, 2003.
  31. Xia X M, Wang H. Gastroesophageal reflux disease relief in patients treated with Rabeprazole 20 mg versus Omeprazole 20 mg: a meta analysis. Gastroenterology Research and practice. Hindawi Publishing Company 2013 http://dx.doi.org/10.1155/2013/327571, accessed on 28/03/2015
  32. Sloan S. 2003. Rabeprazole-based therapy in the management of symptomatic gastroesophageal reflux disease. Am J Gastroenterol, 98(3 Suppl): S49–S55.
  33. Furuta T, Sugimoto M, Shirai N, Ishizaki T. CYP2C19 pharmacogenomics associated with therapy of Helicobacter pylori infection and gastro-esophageal reflux diseases with a proton pump inhibitor. Pharmacogenomics. 2007; 8:1199–1210.
  34. Shirai N, Furuta T, Moriyama Y, et al. Effects of CYP2C19 genotypic differences in the metabolism of omeprazole and Rabeprazole on intragastric pH. Aliment Pharmacol Ther. 2001; 15: 1929–1937.
  35. Saitoh T, Fukushima Y, Otsuka H, et al. Effects of rabeprazole, lansoprazole and omeprazole on intragastric pH in CYP2C19 extensive metabolizers. Aliment Pharmacol Ther. 2002; 16: 1811–1817.
  36. Yamagishi H, Koike T, Ohara S, et al. Early effects of Lansoprazole orally disintegrating tablets on intragastric pH in CYP2C19 extensive metabolizers. World J Gastroenterol. 2008; 14:2049–2054.
  37. Furuta K, Adachi K, Ohara S, et al. Relationship between the acid-inhibitory effects of two proton pump inhibitors and CYP2C19 genotype in Japanese subjects: a randomized two-way crossover study. J Int Med Res. 2010; 38: 1473–1483.
  38. Nagahara A, Suzuki T, Nagata N, Sugai N, Takeuchi Y, Sakurai K, Miyamoto M,et al. A multicentre randomised trial to compare the efficacy of omeprazole versus rabeprazole in early symptom relief in patients with reflux esophagitis. J Gastroenterol (2014) 49:1536–1547. DOI 10.1007/s00535-013-0925-8

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International Journal of Sciences is Open Access Journal.
This article is licensed under a Creative Commons Attribution 4.0 International (CC BY 4.0) License.
Author(s) retain the copyrights of this article, though, publication rights are with Alkhaer Publications.

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